Comparing two treatments for severe urinary symptoms in men with prostate enlargement
Non-inferiority, Randomised, Open-label Clinical Trial on the Effectiveness of Transurethral Microwave Thermotherapy Compared to Prostatic Artery Embolisation in Reducing Severe Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia
This study is testing whether a new heat treatment or a blood vessel blocking procedure can help men with prostate enlargement feel better and improve their urinary symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Copenhagen, Copenhagen N and 2 other locations) |
| Trial ID | NCT05686525 on ClinicalTrials.gov |
What this trial studies
The TUMT-PAE-1 trial is a randomized clinical trial designed to evaluate the effectiveness of transurethral microwave thermotherapy (TUMT) versus prostatic artery embolization (PAE) in alleviating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The study will assess urinary symptoms six months post-procedure using the International Prostate Symptom Score (IPSS) and will also analyze patient-reported outcomes related to satisfaction and quality of life. Both treatments are less invasive alternatives to the traditional surgical option of transurethral resection of the prostate (TURP), which may not be suitable for all patients. The trial aims to determine if TUMT is non-inferior to PAE in managing these symptoms.
Who should consider this trial
Good fit: Ideal candidates include men over 70 with severe LUTS due to BPH who are not suitable for medical treatment or prefer not to undergo it.
Not a fit: Patients with active bladder cancer, neurogenic LUTS, or those with current urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide men with BPH a less invasive treatment option that effectively reduces urinary symptoms.
How similar studies have performed: Previous studies have shown both TUMT and PAE to be effective in reducing LUTS, but this trial aims to directly compare their effectiveness in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and the willingness to sign an informed consent. * Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment or not patient preference. * Severe urinary symptoms on IPSS (IPSS score ≥ 20). * Bladder outlet obstruction (BOO) is defined by Qmax ≤ 15ml/sec, based on uroflowmetry. * Prostate volume at minimum 50 ml measured by TRUS or MR. * Men with prostate cancer in Active Surveillance or Watchful Waiting who have LUTS due to a large BPH component are allowed. * Indwelling catheter or intermittent catheter is allowed. In this case baseline IPSS is 35 points. Exclusion Criteria: * Active bladder cancer (patients with pTa low-grade tumors are allowed). * Previous pelvic radiation for cancer treatment. * Bladder stones (inclusion is allowed after removal). * Current urethral strictures or bladder neck contracture. * Neurogenic LUTS. * Symptomatic urinary tract infection at the time of intervention. * Documented bacterial prostatitis in the last year. * Severe atheromatous disease or other pathology preventing catheter-based intervention (as rated on CT angiography by an interventional radiologist). * Allergy to iodinated contrast media. * Renal failure defined as estimated glomerular filtration rate (eGFR) \< 35ml/min. * High bleeding risk (spontaneous international normalized ratio (INR) \> 1.6). * Contraindication to conscious sedation (if requested by the patient). * Prostate median lobe defined by treating physician. * Urethral colliculus to bladder neck length \<35mm.
Where this trial is running
Copenhagen, Copenhagen N and 2 other locations
- Urological Research Unit, Rigshospitalet — Copenhagen, Copenhagen N, Denmark (Recruiting)
- Department of Urology, Herlev-Gentofte Hospital — Gentofte Municipality, Hellerup, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
Study contacts
- Study coordinator: Anna Kristensen-Alvarez, MD
- Email: anna.kristensen-alvarez@regionh.dk
- Phone: +4535456152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.